NCT00221260

Brief Summary

To investigate if the use of perioperative neuraxial blockade reduces post-operative mortality and cardiorespiratory events compared to intraoperative general anesthesia AND postoperative IV narcotic analgesia. This is a feasibility study to determine if recruitment and execution of the protocol could be done in a timely manner in a much larger trial

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2005

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

September 18, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

September 25, 2008

Status Verified

September 1, 2008

Enrollment Period

2.3 years

First QC Date

September 18, 2005

Last Update Submit

September 24, 2008

Conditions

Post Operative Pain Control

Keywords

Analgesiaanesthesia

Outcome Measures

Primary Outcomes (1)

  • Combined mortality, MI, cardiac arrest, post operative pneumonia , and respiratory failure

Secondary Outcomes (1)

  • DVT, pulmonary embolism, TIA, CVA, CHF, clinically significant bradycardia/hypotension

Interventions

anesthesiaPROCEDURE

Intraoperative general anesthesia AND postoperative IV narcotic analgesia.

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects at high risk of cardio-respiratory complications post operatively.

You may not qualify if:

  • Contraindication to epidural anesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vancouver General Hospital, Clinical Health Research Unit

Vancouver, British Columbia, V5Z 1L8, Canada

Location

Related Publications (1)

  • Choi PT, Beattie WS, Bryson GL, Paul JE, Yang H. Effects of neuraxial blockade may be difficult to study using large randomized controlled trials: the PeriOperative Epidural Trial (POET) Pilot Study. PLoS One. 2009;4(2):e4644. doi: 10.1371/journal.pone.0004644. Epub 2009 Feb 27.

    PMID: 19247497DERIVED

MeSH Terms

Conditions

Agnosia

Interventions

Anesthesia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Study Officials

  • Peter Choi, MD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 18, 2005

First Posted

September 22, 2005

Study Start

September 1, 2005

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

September 25, 2008

Record last verified: 2008-09

Locations

CA(1)